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Lead Auditor

Our in-depth course will provide all the resources you need to operate as a lead auditor

Overview

For years, AAMI courses have been the gold standard for training on the implementation of FDA 21 CFR Part 820 Quality System Regulation and ANSI/AAMI/ISO 13485: 2016/(R)2019. Now, auditors can also benefit from the expertise and rigor of AAMI faculty as they learn today’s best practices for conducting internal audits and supplier audits for compliance with FDA, ISO, MDSAP and EU MDR requirements. We’ll also provide coverage of ASQ/ANSI/ISO 19011:2018, Guidelines For Auditing Management Systems.

What to expect

Over two information-packed, interactive days, participants will learn:
  • Current requirements for internal audits in today's international medical device market
  • Best practices in the interpretation and application of AAMI and other standards
  • How to conduct effective “remote/virtual” QMS audits.
  • Hands-on advice on how to meet FDA expectations for audit procedures, auditor qualifications and audit records
  • The latest on MDSAP and EU MDR status and best practices for working with Notified Bodies         

Materials

Registration includes:
  • a copy of ANSI/AAMI/ISO 13485: 2016/(R)2019 (a $249 retail value)
  • OnDemand access to the recordings following the event (you don’t have to be available live to take advantage of all the learning)
  • a QMS auditing exam qualification record
  • access to the AAMI Alumni community group         

Virtual Training Information

Our virtual training environment allows you to have direct interaction with your instructors and your fellow attendees. AAMI uses Zoom for virtual classes. You can test your connectivity and ability to use Zoom at zoom.us/test.
For virtual training courses, we request that you register at least one week in advance of the course start date to allow sufficient time for shipping of training materials and devices (Please allow two weeks for non-U.S. addresses). If you register within these time frames, AAMI cannot guarantee you will receive material prior to the start of the course but you will have access to digital versions of the materials. If you have any questions, please email education@aami.org.

Faculty

Mark Walker

Senior Faculty, AAMI

Mr. Walker is a senior faculty member for the Association for the Advancement of Medical Instrumentation (AAMI) and has been teaching since 2012.  He is a contributing author for The Quality System Compendium: CGMP Requirements and Industry Practice, Fourth Edition.  He has provided consulting services for over 25 years to Medical Device, Pharma and Biotech companies on FDA's Quality System Regulation (21 CFR 820) and ISO Quality Management system (ISO 13485) to include regulatory compliance, computer systems validation, medical device software design and development, equipment qualification, internal and supplier auditing, quality system development, quality system training, general IT and risk management services.

Mary Vater

Mary Vater is an experienced Medical Device Quality and Regulatory Affairs consultant with a history of working on diverse products within the medical device industry. Her technical background is in engineering product development with a degree focused in Biomedical Engineering. Mary has helped over 30 different companies achieve their Quality and Regulatory goals, with a growing record of successful FDA clearances, CE marks, and QMS certifications.